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Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01239069
First Posted: November 11, 2010
Last Update Posted: May 21, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Santen Inc.
November 9, 2010
November 11, 2010
May 21, 2014
November 2010
October 2011   (Final data collection date for primary outcome measure)
Efficacy of DE-110 [ Time Frame: 12 weeks ]
Same as current
Complete list of historical versions of study NCT01239069 on ClinicalTrials.gov Archive Site
  • Individual Response Rate [ Time Frame: 12 weeks ]
  • Individual Efficacy [ Time Frame: 12 weeks ]
  • Individual Symptoms [ Time Frame: 12 weeks ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of DE-110 Ophthalmic Suspension for the Treatment of Dry Eye Disease
A Phase II, Prospective, Randomized, Observer-masked, Parallel-group, Multi-center Study Assessing the Safety and Efficacy of Two Concentrations Compared to Placebo for the Treatment of Dry Eye Disease
Investigate the Safety and Efficacy of Two Concentrations of DE-110 Compared to Placebo for the Treatment of Dry Eye Disease
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Dry Eye
  • Drug: DE-110 ophthalmic suspension high dose
    ophthalmic suspension; high dose; QID
  • Drug: DE-110 ophthalmic suspension low dose
    ophthalmic suspension; low dose; QID
  • Other: Placebo
    DE-110 ophthalmic suspension vehicle;QID
  • Experimental: DE-110 ophthalmic suspension high dose
    Intervention: Drug: DE-110 ophthalmic suspension high dose
  • Experimental: DE-110 ophthalmic suspension low dose
    Intervention: Drug: DE-110 ophthalmic suspension low dose
  • Placebo Comparator: Placebo
    Intervention: Other: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
140
October 2011
October 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Confirmed diagnosis of dry eye
  • Not wear contact lenses during study
  • 18 years or older
  • Understand and provide written consent
  • Negative pregnancy test and use acceptable method of contraception

Exclusion Criteria:

  • Use of any topical ocular medication
  • Any type of ocular surgery
  • Diagnosis of on-going ocular infection and/or allergic conjunctivitis
  • Uncontrolled systemic conditions/lid abnormalities
  • Corneal transplants
  • Females who are pregnant, nursing or planning a pregnancy
  • Participation in another drug trial concurrently or within 30 days prior to study
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01239069
30-002
Not Provided
Not Provided
Not Provided
Santen Inc.
Santen Inc.
Not Provided
Not Provided
Santen Inc.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP